Recruiting

Medication Safety

Sponsor:

UCLA

Code:

NCT02292056

Conditions

Mental Disorders

Contraception

Chemical Teratogen Exposure

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

1-on-1 counseling

Study Details

Brief summary:

There is currently limited research that addresses the unique medication safety and family planning needs among women of reproductive age with psychiatric conditions. The study will research the feasibility of a novel individualized 1-on-1 counseling session at the Gifford Clinic in the Department of Psychiatry at UCSD that will help women in this population better understand: 1) which of their medications are safe to use in pregnancy, 2) provide education regarding the importance of using contraception and which contraceptive choices are available to them, and 3) raise awareness of any drug-drug interactions that may exist between their medications and their chosen method of contraception. Patients will be given questionnaire to assess their contraceptive utilization. They will also be given a before and after quiz to allow for an objective measure of the patient's increase in knowledge regarding medication safety and contraceptive choices as a result of the investigators intervention.

Conditions

Mental Disorders

Contraception

Chemical Teratogen Exposure

Study ID

NCT02292056

Start date

Sep, 2013

Status verified date

Nov, 2014

Completion date

Oct, 2015

Anticipated

Primary completion date

Oct, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Presenting for follow up psychiatric visit
  • Ethnic Background: will include only english speaking participants (MotherToBaby counselors are only able to speak English)
  • Level of Education: No limitation
  • Health Status: at least one psychiatric condition for which they are taking medication
  • Sexually active with Men

Exclusion Criteria:

  • Planning to become pregnant
  • Not sexually active with men
  • History of hysterectomy, bilateral oophorectomy, or surgical sterilization
  • Decisionally impaired - using post-consent instrument to assess decisional capacity. If a potential participant does not score 100% on post-consent instrument, then she will be excluded from participation.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Counseling Group

Participation in the study will be completed in a single session and will involve a pre-counseling questionnaire, followed by a pre-counseling quiz, individualized counseling session, post-counseling quiz and post-counseling questionnaire.

Interventions

1-on-1 counseling

1. Precounseling questionnaire collecting demographic information, contraception information, and reasons for choosing contraceptive method
2. Precounseling quiz: assess baseline level of knowledge regarding medication safety and contraceptive option.
3. Counseling: completed by MotherToBaby counselor about the safety of their medications for use in pregnancy.
4. 10 minute video entitled "The Contraceptive Choice Project: Which Birth Control Method is Right for You?" by Washington University in St. Louis.
5. Post-Counseling Quiz to assess whether specialized training impacted their understanding of medication safety and contraceptive options.
6. Post-Counseling Questionnaire: assess contraceptive plans and satisfaction with counseling

Primary outcome measure

  • Increase in Patient Knowledge [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Sheila Mody, MD MPH

619-543-6777smody@ucsd.edu

Locations

Gifford Clinic at UCSD Outpatient Psychiatry

Recruiting

San Diego, California, United States, 92103

Contacts

Sheila Mody, MD MPH

619-543-6777smody@ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Nov 17, 2014

Last verified

Nov, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2014-11-17.